CLASS II Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report

Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj recalled

Innovative Intrathecal Solutions is recalling Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, Injectable, distributed in California, Maine, Texas. The recall was initiated on 26 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #02282020@30, Expires after 04/28/2020

Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1099-2020
FDA event ID: 85351
Recalling firm: Innovative Intrathecal Solutions, Murrieta, CA
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2020
FDA classified: 6 Apr 2020
Reported: 15 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

26 Mar 2020	Recall initiated by company
6 Apr 2020	Classified by FDA	+11 days
15 Apr 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Where it was distributed

Patient Distribution list includes addresses in the following states: CA, ME, TX

California Maine Texas

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot #02282020@30, Expires after 04/28/2020

Where was it sold?

Patient Distribution list includes addresses in the following states: CA, ME, TX

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 85351

This product is part of a recall event; the main page for the event is Testosterone Cypionate In Sesame Oil 200mg/ml, Injectable recalled.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020	CLASS II	Testosterone Cypionate In Sesame Oil 200mg/ml, Injectable recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020	CLASS II	MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020	CLASS II	Methylcobalamin Soln recalled by Innovative Intrathecal	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020	CLASS II	Hydroxyprogesterone Caproate (BUD) 350mg/ml , Injectable recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	Hydroxyprogesterone Caproate (BUD) 350mg/ml , Injectable recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020Drug	CLASS II	Methylcobalamin Soln recalled by Innovative Intrathecal	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020Drug	CLASS II	MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
15 Apr 2020Drug	CLASS II	Testosterone Cypionate In Sesame Oil 200mg/ml, Injectable recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX

Other Alprostadil recalls

All 41

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled	TMC Acquisition	Sterility	Nationwide
15 Jun 2022Drug	CLASS III	Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
17 Nov 2021Drug	CLASS II	Alprostadil 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR